FDA’s Guidance Document Recommends Less Antibiotics

The Food and Drug Administration (FDA) issued a guidance document Monday that could lead to the elimination or costly review of previously approved animal health products

Jun 29, 2010

The Food and Drug Administration (FDA) issued a guidance document Monday that could lead to the elimination or costly review of previously approved animal health products, according to the National Pork Producers Council (NPPC), which says there appears to be no science behind FDA’s guidance.

The FDA document calls for antibiotics that are “medically important” to humans to only be used in animals when necessary to assure their health. Those antibiotics should be administered with veterinary oversight or “consultation.” FDA said while the document does not carry the weight of a rule, the guidance would be used to develop public policy on animal antibiotic use.

“This guidance could eliminate certain antibiotics that are extremely important to the health of animals,” says NPPC President Sam Carney, an Adair, IA, pork producer. “FDA didn’t present any science on which to base this, yet it could have a tremendous negative impact on animal health and, ultimately, the safety of food. As we know, healthy animals produce safe food, and we need every available tool to protect animal health.”

Under the guidance document, antibiotics that currently are not labeled for preventing, treating or controlling diseases could continue to be used if after undergoing a second rigorous FDA approval process, one of those label claims is proved. That process can take seven to 10 years and can cost pharmaceutical firms millions of dollars.

NPPC expressed concern about FDA’s call for animal antibiotics to be used under the “oversight” of, or in “consultation” with, a veterinarian. NPPC said a requirement that all antibiotics be accompanied by feed directives, for example, could be a problem given the country’s severe shortage of large animal veterinarians.

“Producers work with their veterinarians to develop animal health plans that include the judicious use of antibiotics,” Carney says. “The industry also has programs, including the FDA-reviewed Pork Quality Assurance Plus program, that educate producers about the responsible use of antibiotics.”

The guidance document from FDA is in response to increasing antibiotic-resistant illnesses in humans, attributed to the use of antibiotics in livestock and poultry production by opponents of modern agriculture.

But NPPC says top scientists with the Centers for Disease Control and Prevention and the National Institutes of Health recently told a U.S. House committee that there is no scientific study that links antibiotic use in food animal production with antibiotic resistance.